A Cluster-Randomized Controlled Trial
AI-Empowered Expert Prescription Intervention for Improving Cardiovascular Prognosis Among Primary-Care Hypertensive Populations: A Cluster-Randomized Controlled Trial
1 other identifier
interventional
14,400
0 countries
N/A
Brief Summary
The goal of this study is to learn if an AI-generated personalized health report combined with face-to-face guidance from cardiologists can help rural adults with high blood pressure control their blood pressure better and reduce heart attacks and strokes. It will also assess the safety and practicality of this approach. The main questions it aims to answer are: Does this intervention increase the proportion of patients who achieve blood pressure below 130/80 mmHg at 18 months? Does it lower the rate of major cardiovascular events (heart attack, stroke, heart failure hospitalisation, or cardiovascular death) over 48 months or longer? Does it improve medication adherence, blood pressure levels, and health knowledge, and is it cost-effective? Researchers will compare three groups of townships: one receiving the full AI-plus-cardiologist intervention, one receiving the same follow-up and education but without the AI report and cardiologist consultation, and one continuing with usual local care. Participants will: Attend regular clinic visits for blood pressure measurements, lab tests, and questionnaires. If in the intervention group, receive an AI-generated personalised health report and a face-to-face consultation with a cardiologist, plus home blood pressure monitoring guidance and health education. Be followed for 48 months or longer to track their blood pressure and any cardiovascular events. All medications used are standard, widely approved blood pressure drugs; side effects are mild and manageable, and participants will be closely monitored. Participation is voluntary, and all personal data will be kept confidential. The study has ethics approval, and informed consent will be obtained from all participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Sep 2026
Longer than P75 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2026
CompletedFirst Submitted
Initial submission to the registry
September 21, 2026
CompletedFirst Posted
Study publicly available on registry
September 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 9, 2031
September 28, 2026
September 1, 2026
5 years
September 21, 2026
September 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary 1
Proportion of Participants Achieving Office Blood Pressure \< 130/80 mmHg at 18 Months
18 months from baseline
Primary 2
Composite Incidence of Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Heart Failure Hospitalization, and Cardiovascular Death at 48 Months or longer.
48 Months or longer from baseline
Secondary Outcomes (8)
Secondary 1
Baseline to 18 months
Secondary 2
18 months from baseline
Secondary 3
18 Months from baseline
Secondary 4
18 Months from baseline
Secondary 5
48 Months or longer from baseline
- +3 more secondary outcomes
Study Arms (3)
Intervention Group
EXPERIMENTALAI-generated personalized health report + cardiologist face-to-face prescription optimization + integrated management
Internal Control Group
ACTIVE COMPARATORIntegrated management (follow-up, education, quality control) without AI report and cardiologist consultation
External Control Group
NO INTERVENTIONRoutine local hypertension management without any study-added intervention
Interventions
Participants receive an AI-powered "2+N" health report covering individualized nutrition plans, lifestyle modification (exercise, weight, smoking, alcohol), and integrated management of hypertension, diabetes, dyslipidemia, hyperuricemia, hyperhomocysteinemia, and obesity. The AI draft is reviewed by a clinical nutritionist and cardiologists from a tertiary hospital. Face-to-face cardiologist consultations are provided for prescription optimization, medication titration, and treatment individualization. Grassroots providers receive training workshops, real-time consultation, monthly case discussions, and quarterly specialist visits. Participants also receive home BP monitoring guidance, regular follow-ups, and health education. All antihypertensives are standard marketed agents (CCB, ACEI, ARB, thiazides) used per guidelines; no investigational products.
Participants receive the same integrated management package as the intervention group, including standardized capacity-building training for healthcare providers (excluding AI report interpretation modules), regular follow-up visits, conventional health education using generic hypertension prevention manuals (non-individualized), home blood pressure monitoring guidance, and the tiered quality control and incentive system. However, they do NOT receive the AI-generated "2+N" personalized health report or accompanying videos, do NOT have cardiologist-led face-to-face prescription training or on-site consultation, and do NOT receive specialist outreach visits. Antihypertensive medications are standard marketed agents prescribed per guidelines; no investigational products are involved. This arm serves as an active comparator to isolate the independent net effect of the AI plus cardiologist intervention component from the background integrated management package.
Eligibility Criteria
You may qualify if:
- Age ≥ 35 years, regardless of gender.
- Meet the hypertension diagnostic criteria: untreated office SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg; or treated with office BP ≥ 130/80 mmHg; or with history of coronary heart disease, stroke, heart failure, diabetes, or chronic kidney disease and office BP ≥ 130/80 mmHg regardless of treatment status.
- Have resided continuously in the township for at least 6 months with no plan for long-term relocation within 3 years.
- Enrolled in the basic medical insurance system.
- Willing to participate and provide written informed consent.
You may not qualify if:
- Pregnant or planning pregnancy within the study period.
- Diagnosed with malignant tumors or terminal illnesses.
- Severe mental disorders or cognitive impairment that precludes compliance with intervention and follow-up.
- Concurrent participation in another hypertension intervention trial.
- Refusal to cooperate with data collection, follow-up, or intervention procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2026
First Posted
September 28, 2026
Study Start
September 10, 2026
Primary Completion (Estimated)
September 9, 2031
Study Completion (Estimated)
September 9, 2031
Last Updated
September 28, 2026
Record last verified: 2026-09